NCT Number: NCT02153359
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
About this study
The investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. To this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 18-50 years of age
- Non-smoker (<100 cigarettes in lifetime)
- Physician diagnosis of asthma
- Symptoms of asthma and/or reliever medication use in the past 6 months
- Living in the current residence >= 6 months within Baltimore
- Enrollment in, and completion of, the observational environmental asthma study "Inhale 1"
Exclusion criteria
- Current diagnosis of another major pulmonary disease, other significant morbidity
- Pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential)
- Planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period
- Current use of an air cleaner in the home
Treatment and study plan
Sham air cleaner
DevicePrimary outcomes
-
PM2.5 Concentration (ug/m^3)
Time frame: Approximately 1 month
Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.
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PM2.5-10 Concentration (ug/m^3)
Time frame: Approximately 1 month
Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.
Secondary outcomes
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Number of Symptom-free Days
Time frame: 7 days
The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.
-
Number of Days With Activity Limitations
Time frame: 7 days
Number of reported days with activity limitations due to asthma symptoms.
-
Number of Nights Disrupted by Asthma Symptoms
Time frame: 7 nights
The number of nights spent sleeping that was disrupted due to asthma symptoms.
-
Number of Days of School/Work Missed Due to Asthma Symptoms
Time frame: 7 days
The number of days of school or work missed due to asthma symptoms.
-
Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms
Time frame: 7 days
The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.
-
Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)
Time frame: Approximately 1 month
The ACCI is a validated clinical tool that measures asthma disease status during routine health care and is valid for use in both black and white populations. The sum of each of the 5 ACCI asthma control domains results in a final ACCI score ranging from 0 (better control) to 19 (worse control).
-
Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Approximately 1 month
The AQLQ is validated clinical tool to assess asthma-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range from 1-7, with higher scores indicating better quality of life.
-
Air Nicotine Concentration (ug/m^3)
Time frame: Approximately 1 month
Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.
-
Bronchoalveolar Lavage Differential Neutrophil Count
Time frame: 1 Day
The percentage of neutrophils in the bronchoalveolar lavage cell count.
-
Bronchoalveolar Lavage Differential Eosinophil Count
Time frame: 1 day
The eosinophil percentage in the bronchoalveolar lavage cell count differential.
-
Pre-bronchodilator Forced Vital Capacity (Litres)
Time frame: 1 day
Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry
-
Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)
Time frame: 1 day
The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
-
FEV1 Percentage of FVC
Time frame: 1 day
The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.
Sponsors and collaborators
Lead sponsor
Johns Hopkins University
Other
Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
Registry information
Acronym: INHALE 2
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 3, 2014
- Registry last updated
- Sep 12, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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